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At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 125,000 employees. Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide! In your role as (Senior) Toxicological Expert (m/f/d), you will be responsible for toxicological evaluations and risk assessments of medical devices in compliance with MDR (EU 2017/745), ISO 10993-17, and related regulatory guidelines.
Job Responsibility:
Derive strategy for toxicological evaluations and risk assessment acc. ISO 10993-17 for different product groups and therapies
Support biocompatibility strategy details including material characterization, sampling of different product groups, chemical-analytical and biological testing as well as overall evaluation
Analyze results of chemical-analytical and biological testing for their toxicological profiles
Create toxicological risk assessments for leachables and extractables studies for all relevant products
Perform toxicological evaluations of substances or if needed assignment of mandates for external toxicologists and review of respective assessments
Support and coordinate with projects and product responsibles how to interpret the findings and measures to be taken, e.g., change of materials or production processes, measures to minimize leachables, etc.
Revise existing toxicological risk evaluations or reports for substances to comply with state-of-the-art data
Drive the global exchange and knowledge increase wrt toxicological evaluation of relevant substance groups and respective measures
Support with toxicological expert know-how and contribute to the overall biocompatibility reports for the products
Requirements:
Successfully completed master’s degree in scientific or engineering or a similar technical field required, such as medical technology
Related working experience: 2–8 years, depending on level (Expert / Senior Expert)
Advanced training in toxicology, e.g., avocational studies, trainings, etc.
Certification as toxicologist or started education highly welcome, e.g., European Registered Toxicologist (ERT) or Board Certified Toxicologist (DABT)
Deep knowledge of ISO 10993 standard series including respective trainings
Significant experience in chemical-analytical as well as biological biocompatibility testing as well as evaluations
What we offer:
Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company